Healthy VolunteersIMAP-1NCT01505049
Immune Memory After Papillomavirus Vaccination
An observational study of Healthy Volunteers, run by Emory University at 1 site in United States.
Trial summary
Vaccines for human papillomavirus (HPV) have been available in the United States since 2006. Early studies have shown a high rate of effectiveness of these vaccines, however it is not known how long this protection will last. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- quadrivalent HPV vaccine
- Type of treatment
- Vaccines
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: we are seeking healthy female volunteers
Who may be able to join
- Female ages 18-26 inclusive (18-30 for women who have been previously vaccinated
- If sexually active and enrolled in unvaccinated group, must use a reliable form of birth control for the first seven months of the study. For the purposes of this protocol a reliable form will be hormonal or barrier contraception. Intrauterine devices and a history of sterilization will also be considered reliable forms of birth control. Abstaining from sex is also a reliable form of contraception.
- Able to give informed consent
- Negative urine pregnancy test at enrollment
Who cannot join
- Currently pregnant, breast feeding or planning a pregnancy
- Underlying immunological disease, such as previously diagnosed HIV infection or history of transplantation, history of splenectomy
- Use of medications with potential immunological effects such as systemic corticosteroids or chemotherapy
- Prior therapy for cervical dysplasia or cervical cancer such as loop excision, laser ablation, cryotherapy or hysterectomy
- Unable to comply with protocol
- Severe allergic reaction (e.g., anaphylaxis) after a previous vaccine dose or to a vaccine component
- An acute illness, including an oral temperature of 100.4 degrees F within three days of visit
- other more specific exclusions may apply to one of the three cohorts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Memory After Papillomavirus Vaccination (IMAP-I) Study . DMID 10-0014
Vaccines for human papillomavirus (HPV) have been available in the United States since 2006. Early studies have shown a high rate of effectiveness of these vaccines, however it is not known how long this protection will last. The IMAP study will look at various parts of the immune system and potential markers for long lived immune responses to this vaccine.
Read the detailed description
Three groups of patients will be recruited for this study. One group will be women who have completed all three vaccinations. The second group will be women who are overdue for their final vaccination. We also recruit women who have not been vaccinated previously.
- Conditions
- Healthy Volunteers
- Being tested
- quadrivalent HPV vaccine
- Keywords
- immunology, vaccination, human papillomavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadrivalent HPV vaccineDrug
Also called Gardasil if the trade name of the quadrivalent HPV vaccine.
For the group who have received two prior doses of vaccine, the third and final dose of vaccine will be given. For the unvaccinated cohort, women will receive all three doses of the vaccine. The second dose of the vaccine will be given two months after the first dose. The third and final dose of the vaccine will be given six months after the first dose.
| Study group | Role | What they receive |
|---|---|---|
| Previously received all three doses of HPV vaccine | This group will consist of 78 women ages 18 to 30 who have received their third dose of vaccine three or more years ago. Recruitment of this group was completed in Sept 2012. | |
| Previously received two doses of HPV vaccine | This group will consist of 78 women ages 18 to 30 who have received two doses of the HPV vaccine. The second dose must have been received six or more months ago. Receives: Drug: quadrivalent HPV vaccine | |
| Unvaccinated Cohort | This group will consist of 45 women who have not received their HPV vaccination. Women ages 18-26 are eligible for this cohort. Recruitment for this group was completed in January 2013. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine markers of immune memory in women receiving quadrivalent HPV vaccine including antibody levels and memory B cells
Measured: 2 years after first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Mulligan, Emory University
- Investigators
- Mark J Mulligan, MD, Principal investigator, Emory UniversityKevin Ault, MD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505049
- Sponsor's protocol ID
- IRB00046117
- Other IDs
- DMID 10-0014
- Acronym
- IMAP-1
- Status last verified
- Jul 2015
- First submitted
- 4 Jan 2012
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Memory After Papillomavirus Vaccination (IMAP-I) Study . DMID 10-0014
- ClinicalTrials.gov ID
- NCT01505049
- Acronym / sponsor ID
- IMAP-1 / IRB00046117
- Conditions
- Healthy Volunteers
- Keywords
- immunology, vaccination, human papillomavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaccines for human papillomavirus (HPV) have been available in the United States since 2006. Early studies have shown a high rate of effectiveness of these vaccines, however it is not known how long this protection will last. The IMAP study will look at various parts of the immune system and potential markers for long lived immune responses to this vaccine.
Detailed description
Three groups of patients will be recruited for this study. One group will be women who have completed all three vaccinations. The second group will be women who are overdue for their final vaccination. We also recruit women who have not been vaccinated previously.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Previously received all three doses of HPV vaccine | – | –This group will consist of 78 women ages 18 to 30 who have received their third dose of vaccine three or more years ago. Recruitment of this group was completed in Sept 2012. |
| Previously received two doses of HPV vaccine | – | Drug: quadrivalent HPV vaccineThis group will consist of 78 women ages 18 to 30 who have received two doses of the HPV vaccine. The second dose must have been received six or more months ago. |
| Unvaccinated Cohort | – | –This group will consist of 45 women who have not received their HPV vaccination. Women ages 18-26 are eligible for this cohort. Recruitment for this group was completed in January 2013. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- we are seeking healthy female volunteers
Key inclusion criteria (4 listed)
- Female ages 18-26 inclusive (18-30 for women who have been previously vaccinated
- If sexually active and enrolled in unvaccinated group, must use a reliable form of birth control for the first seven months of the study. For the purposes of this protocol a reliable form will be hormonal or barrier contraception. Intrauterine devices and a history of sterilization will also be considered reliable forms of birth control. Abstaining from sex is also a reliable form of contraception.
- Able to give informed consent
- Negative urine pregnancy test at enrollment
Key exclusion criteria (8 listed)
- Currently pregnant, breast feeding or planning a pregnancy
- Underlying immunological disease, such as previously diagnosed HIV infection or history of transplantation, history of splenectomy
- Use of medications with potential immunological effects such as systemic corticosteroids or chemotherapy
- Prior therapy for cervical dysplasia or cervical cancer such as loop excision, laser ablation, cryotherapy or hysterectomy
- Unable to comply with protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quadrivalent HPV vaccineAlso: Gardasil if the trade name of the quadrivalent HPV vaccine.For the group who have received two prior doses of vaccine, the third and final dose of vaccine will be given. For the unvaccinated cohort, women will receive all three doses of the vaccine. The second dose of the vaccine will be given two months after the first dose. The third and final dose of the vaccine will be given six months after the first dose. | Drug | Previously received two doses of HPV vaccine |
Primary outcome
To examine markers of immune memory in women receiving quadrivalent HPV vaccine including antibody levels and memory B cells
Time frame: 2 years after first vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J Mulligan, MD principal investigator
Emory University
Kevin Ault, MD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine markers of immune memory in women receiving quadrivalent HPV vaccine including antibody levels and memory B cells (time frame: 2 years after first vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.